Curatolo N, Prot-Labarthe S, Auvin S, Sachs P, Brion F, Bourdon O
Service de pharmacie, hôpital Robert-Debré, AP-HP, université Paris-Descartes, Paris, France.
Rev Neurol (Paris). 2010 May;166(5):528-33. doi: 10.1016/j.neurol.2009.10.022. Epub 2010 Jan 15.
Injectable lorazepam (IL) is marketed in many countries but in France is only available within the framework of a compassionate use program for refractory status epilepticus. This study aims to evaluate the differences of pediatric use and status of IL in the hospitals of the Mother-Child French-speaking Network (Réseau mère-enfant de la francophonie, i.e., RMEF).
Inclusion criteria are: firstly, RMEF member; secondly, one site per town; thirdly, all the Assistance publique-Hôpitaux de Paris hospitals. After a phone-recruitment in each selected hospital, a survey was sent by e-mail. The data collected concerned the number of beds in the hospital, the official status of IL, its place in the therapeutic strategy, in hospital consumption in 2008 (in milligram) and the therapeutic alternatives.
Among the 18 hospitals selected, 17 were contacted and 12 (70%) replied. IL is not marketed in Tunisia and Lebanon. In Switzerland, Canada and Belgium, IL is marketed and used in all the polled hospitals (6.2 to 48.0mg per bed). In France, only the Robert Debré Hospital uses it (3.2mg per bed). In the countries where it is marketed, IL was firstly prescribed for the studied indication. In the other countries, injectable diazepam was the first line treatment (six out of eight hospitals).
DISCUSSION/CONCLUSION: France is the only country where IL is available though not marketed. The pharmacokinetic data favor use of IL instead of its principal therapeutic alternative (injectable diazepam) but no currently available evidence concludes that IL is superior to diazepam in the management of pediatric status epilepticus. The official indication of IL in France (last intention) is in contradiction with its use in the countries where it is marketed and with the data of the literature in favor of the first intention. This works presents the first evaluation on the use of IL in pediatric status epilepticus in the RMEF hospitals. It highlights the discrepancies in the management of status epilepticus in comparable pediatric hospitals.
注射用劳拉西泮(IL)在许多国家都有销售,但在法国仅在难治性癫痫持续状态的同情用药计划框架内可用。本研究旨在评估法语区母婴网络(Réseau mère - enfant de la francophonie,即RMEF)医院中IL的儿科使用情况和现状。
纳入标准为:首先,是RMEF成员;其次,每个城镇一个地点;第三,所有巴黎公立医院。在每家选定医院进行电话招募后,通过电子邮件发送调查问卷。收集的数据包括医院的床位数、IL的官方状态、其在治疗策略中的地位、2008年的院内消耗量(以毫克计)以及治疗替代方案。
在选定的18家医院中,联系了17家,12家(70%)回复。IL在突尼斯和黎巴嫩没有销售。在瑞士、加拿大和比利时,IL有销售且在所调查的所有医院中都有使用(每张床位6.2至48.0毫克)。在法国,只有罗伯特·德布雷医院使用它(每张床位3.2毫克)。在有销售的国家,IL首先用于所研究的适应症。在其他国家,注射用地西泮是一线治疗药物(八家医院中有六家)。
讨论/结论:法国是唯一有IL但未销售的国家。药代动力学数据支持使用IL而非其主要治疗替代药物(注射用地西泮),但目前尚无证据表明IL在小儿癫痫持续状态的管理方面优于地西泮。IL在法国(最后意向)的官方适应症与其在有销售的国家的使用情况以及支持首选意向的文献数据相矛盾。这项工作展示了对RMEF医院中IL用于小儿癫痫持续状态的首次评估。它突出了可比儿科医院在癫痫持续状态管理方面的差异。